Skinonorm

General characteristics. Structure:

Active ingredient: 200 mg of the azelaic acid in 1 g of cream.

Excipients: propylene glycol, paraffin soft, white, cetostearyl alcohol, a makrogolglitserin hydroxystearate, a macrogoal cetostearyl ether, a macrogoal 400, stearic acid, glycerin, diethanol amide, methylparahydroxybenzoate, пропилпарагидроксибензоат, the water purified.

Antiacne antimicrobic means for topical administration.

Pharmacological properties:

Pharmacodynamics. Antimicrobic action and direct influence on a follicular hyperkeratosis are considered as a basis of a therapeutic effectiveness of cream Skinonorm in treatment of acne rash. Skinonorm causes clinically significant decrease in density of colonization of Propionibacterium acnes and significant decrease in fraction of free fatty acids in lipids of a surface of skin.

Pharmacokinetics. After putting cream the azelaic acid gets into all layers of skin of the person. Penetration happens with greater speed through the affected skin, than through unimpaired. After single drawing on the surface of skin of 1 g of the azelaic acid (5 g of cream) 3,6% of the put dose are subcutaneously absorbed. A part of the azelaic acid absorbed through skin is excreted with urine in not changed look, a part — is exposed to β-oxidation, turning into dicarboxylic acids with less short chain (C7, C5) which also reveal in urine.

Indications to use:

- eels ordinary (Acne vulgaris)

Route of administration and doses:

Apply on affected areas of skin and slightly rub 2 times a day (in the morning and in the evening). About 2,5 cm (0,5 g) of a cream column from a tuba are enough for all surface of a face. In case of excessive irritation of skin it is necessary to reduce temporarily or the number of Skinonorm who is put, or the frequency of use of drug to 1 time a day before disappearance of irritation.

If necessary it is possible to interrupt treatment for several days. Duration of a course of treatment can change depending on an individual picture of a disease and is defined by degree of its weight. At patients with an acne notable improvement is noted, as a rule, in 4 weeks. However for achievement of optimum result Skinonorm continuously for several months is recommended to use drug. There is a clinical experience of continuous administration of drug throughout the period till 1 year.

Features of use:

It is necessary to avoid hit of cream in eyes, and also on mucous membranes of a nose, lips and a mouth. After each use of cream Skinonorm it is necessary to wash up hands.

In cases of strongly expressed irritation of skin in the first weeks of treatment it is possible to apply 1 times/days; short-term drug withdrawal is also possible. After disappearance of symptoms of irritation of skin it is necessary to resume regular use of medicine in the recommended dose.

Skinonorm it is possible to apply in combination with other methods of therapy of acne rash. At the same time correction of the mode of dosing of at the same time applied medicines is possible.

Children. Safety and efficiency of cream of Skinonorm for treatment of ordinary eels at children aged up to 12 years are not established. Dose adjustment by Skinonorm for patients at the age of 12 – 18 years is not required.

Pregnancy and period of a lactation. Considering low system bioavailability and a hypotoxicity of the azelaic acid perhaps careful use of medicine during pregnancy and a lactation.

Management of transport and mechanisms. Skinonorm cream does not exert impact on ability to drive the car and work with mechanisms.

Side effects:

Frequency of the side reactions given below was determined by results of clinical tests and corresponded to the following indicators characterizing the frequency of their occurrence:
- very often: ≥1/10;
- often:> 1/100 <1/10;
- infrequently:> 1/1000 <1/100;
- seldom:> 1/10 000 <1/1000;
- very seldom: <1/10 000, including separate messages.

Class of system of bodies	Very often	Often	Infrequently	Seldom
Diseases of skin and hypodermic cellulose			seborrhea, acne, skin depigmentation	cheilitis
General disturbances	burning, itch, erythema	peeling, pain, dryness, discoloration, irritation	paresthesias, dermatitis discomfort, hypostasis	bubbles, eczema, heat, ulcer
Disturbances of immune system				hypersensitivity to medicine

Interaction with other medicines:

Clinically significant interaction of the azelaic acid with other medicines is unknown so far.

Contraindications:

- Hypersensitivity to medicine components.
- Children's age up to 12 years.

Overdose:

Now cases of overdose of the azelaic acid are not described.

Storage conditions:

To store at a temperature not above +25 °C. To store in the place, unavailable to children. Period of validity 2 years.

Issue conditions:

Without recipe

Packaging:

On 15,0 g, 30,0 g and 50,0 g in the tubas placed together with a leaf insert in packs from a cardboard.